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Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data

PURPOSE: To evaluate the impact of including a medicine in the list of medicinal products subject to additional monitoring (AM) on the reporting of adverse drug reactions (ADRs) in the european economic area (EEA). METHODS: Interrupted time series using the monthly number of EEA ADR reports in Eudra...

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Publicado en:Pharmacoepidemiol Drug Saf
Autores principales: Segec, Andrej, Slattery, Jim, Morales, Daniel R., Januskiene, Justina, Kurz, Xavier, Arlett, Peter
Formato: Artigo
Lenguaje:Inglês
Publicado: John Wiley & Sons, Inc. 2020
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Acceso en línea:https://ncbi.nlm.nih.gov/pmc/articles/PMC7898803/
https://ncbi.nlm.nih.gov/pubmed/33197106
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pds.5174
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